Ending a Clinical Trial with Clean Data:

It’s Achievable

Bypass Angioplasty Revascularization

Investigation 2 Diabetes (BARI 2D)

Sue Janiszewski

University of Pittsburgh

Society for Clinical Trials

May 18, 2010

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BARI 2D

The Bypass Angioplasty Revascularization Investigation 2 Diabetes (BARI 2D) trial is sponsored by the National Heart, Lung and Blood Institute (NHLBI) and receives substantial funding from the National Institute of Diabetes and Digestive and Kidney

Diseases (NIDDK).

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BARI 2D SponsorsBARI 2D received major funding from

GlaxoSmithKline

BARI 2D received significant funding from

Bristol-Myers Squibb Medical Imaging, Inc.

Astellas Pharma US, Inc.

Merck & Co., Inc

Abbott Laboratories, Inc.

Pfizer, Inc.

BARI 2D also received generous support from

Abbott Laboratories Ltd., MediSense Products

Bayer Diagnostics

Becton, Dickinson and Company

J. R. Carlson Laboratories, Inc.

Centocor, Inc.

Eli Lilly and Company

LipoScience, Inc.

Merck Sante

Novartis Pharmaceuticals Corporation

Novo Nordisk, Inc.3

BARI 2D Sites**University of Sao Paulo Heart Institute

**Toronto General Hospital/University Health Network

**Texas Health Science @ San Antonio/South Texas

*Mayo Clinic-Rochester

*Mexican Institute of Social Security

*University Hospitals of Cleveland/CASE Medical School

*Memphis VA Medical Center/University of Tennessee

*Montreal Heart Institute/Hotel-Dieu-CHUM

*Albert Einstein College of Medicine/Montefiore

*Fuqua Heart Center/Piedmont Hospital

*University of Alabama @ Birmingham

*Northwestern University Medical Center

*Na Homolce Hospital

*Ottawa Heart Institute/Ottawa Hospital-Riverside Campus

*New York Medical College/Westchester Medical Center

*Emory University

*Washington Hospital Center /Georgetown University

*Quebec Heart Institute/Laval Hospital

*University of British Columbia/Vancouver Hospital

NYU School of Medicine

Lahey Clinic Medical Center

University of Virginia

University of Minnesota

St Luke’s/Roosevelt Hospital Center

University of Florida

St Louis University

University of Texas @ Houston

Kaiser-Permanente Medical Center

Henry Ford Heart & Vascular Institute

Boston Medical Center

Fletcher Allen Health Care

Jim Moran Heart & Vascular Institute

Baylor College of Medicine

Duke University

University of Maryland Hospital

University of Chicago Medical Center

University of Pittsburgh Medical Center

Washington University/Barnes Jewish Hospital

Mount Sinai Medical Center

Mid America Heart Institute

University of Michigan

Johns Hopkins Bayview Medical Center

Brown University/Rhode Island Hospital

Houston VA Medical Center

New York Hospital Queens

Wilhelminen Hospital

St Joseph Mercy Hospital/Michigan Heart PC

Ohio State University Medical Center

Mayo Clinic-Scottsdale

** ≥ 100 participants * ≥ 50 and < 100 participants

North America - 1937 participants (USA:1499 participants, Canada: 353 participants, Mexico: 85 participants)

South America - 356 participants (Brazil: 356) Europe - 75 participants (Czech Republic: 65, Austria: 10)

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Core Laboratories (separate data collected at):AngiographicBiochemistry/GeneticsFibrinolysisECGNuclearEconomics

Management Centers (managed pt care, so timely data entry necessary):

Cardiovascular/HypertensionDiabetesLipidsLifestyle

BARI 2D

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Count2,368 Participants

49 Clinical Sites

6 Countries

6 Core Laboratories

4 Management Centers

1 Coordinating Center

36 forms, > 2,600 variables

How many data managers? 2 - 4 data managers6

BARI 2D Time Line

Jan 1 April 1 March 31 Jan 1 Nov 30

2001 2001 2005 2007 2008(Vanguard) (All sites)

Recruitment Recruitment Closeout Follow-up

Begins Complete Begins Ends

Average F/U 5.3 yrs

Steering Committees 2x/yr and then once after

recruitment ended7

Sources of Data

Visits Baseline (up to 16 forms)

Monthly visits first 6 months, then quarterly(1-5)

More extensive annual data collection (3 forms)

Events Revascularization-PCI/CABG (2 forms)

Stroke(2 forms)

Myocardial Infarction (2 forms)

Severe Hypoglycemia (1 form)

Death (2 forms)

Core Labs Angiograms

ECGs

Test results

Samples

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Who is Doing Data Entry?

Data collection by coordinator Data Entry by someone else

Perfect world

Reality

Coordinator collecting and tracking down data

for BARI 2D AND other projects

AND entering the data too

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BARI 2D Data Entry

Tools for data entry and cleaning used:

During the trial

As the trial approached the end

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BARI 2D Data EntryHow was data entered? Via a web-based data entry system called MATRIX.

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BARI 2D Data Entry

Features include

• double entry for key forms

(enter and verify)

• edits for specific entry errors

• customized reports

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Site Specific ReportsForms Not Entered

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Site Specific ReportsErrors in Entered Forms

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Site Core Lab Tracking ReportWhat a Core Lab is Missing

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Site Data Compliance report

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Coordinating Center Site Tracking Reports

Forms Overview

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Coordinating Center Site Tracking Reports

Events

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BARI 2D Data Entry

Tools for data entry and cleaning used:

During the trial

As the trial approached the end

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Data Cleaning Contributors • Coordinators - provide valuable insight

(ranges/possible edits)

• CC Administrators - brain storming strategies and

contacting site leadership

• Site leadership - make sure coordinator has

adequate time/support

• Data managers - responsible for dataset creation too,

during which errors were found

(e.g. Baseline)

• Analysts - find errors when using data in analyses

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BARI 2D Closeout

How long were patients followed? – Anywhere from 3-6 yrs of

follow-up

When to stop? – Chose anniversary of randomization starting

December 1, 2007 and ending November 30, 2008.

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Specialized ReportsFor Sites

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More Specialized ReportsFor Sites

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Step by step strategyfor cleaning data

First get data entered

Then make sure the data is clean

Which data to emphasize first?

Events – can concentrate on one at a time

important as endpoints

Visits – after done with events

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Strategy 1 – Event a month club

1

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Emphasize the positive

Group goals

Group accomplishments

Individual sites

recognized for meeting

goals

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Strategy 2 – Frequent contact w/data manager

By e-mail

By phone

Friendly neighborhood

data manager

By fax

(confirming

edit values)Very helpful to

set dates to talk

& work through

data issues

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Strategy 3 – Schedule pt. final visit early

Want to make sure last visit takes place because of the valuable information it yields.

If patient has to reschedule, you still have plenty of time before the end of the study.

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Strategy 4 – Use Steering Committee Meeting

for one-on-one meetings

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PI Involvement When Necessary

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BARI 2D Conclusions

Planning

Persistence

Plain hard work

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Personal touch

BARI 2D

Will bring you to the finish lineWITH CLEAN DATA

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